Open Label to Study to Evaluate Effect of Alfilbercept on Patients With (FVPED) Fibrovascular Pigment Epithelial Detachment

This is an Open Label Study to Evaluate the Efficacy of Intravitreal Aflibercept Injection 2mg in Patients With a Persistent FVPED Despite at Least 6 Consecutive Injections With Ranibizumab 0.5 mg

This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.

Study Overview

• Status: Withdrawn
• Conditions: Fibrovascular Pigment Epithelial Detachment
• Intervention / Treatment: Drug: Aflibercept

Detailed Description

This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.

Patients being evaluated at VRM New York with neovascular AMD who have persistent sub-foveal FVPED on OCT despite at least 6 consecutive ranibizumab injections will be considered for the study.

We aim to recruit 25 patients in the study. There have been no statistical tests to calculate sample size; sample size of 25 patients is chosen, making sure that it is feasible financially to conduct the study and logistically to complete the study within 24 weeks. This is a pilot study to assess the effects of intravitreal aflibercept injection on chronic, persistent FVPEDs; currently there is no data regarding visual and anatomical outcomes for this group of patients.

Patients will be reviewed at baseline and then at 4 week intervals (28 ± 7 days). They will receive intravitreal intravitreal aflibercept injection 2mg at each visit. The primary end point of the study is 24 weeks from baseline. Patients who complete the study will have received 6 injections of intravitreal aflibercept injection 2mg.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Vitreous Retina Macula Consultants of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 50 years
• Subfoveal FVPED assessed using clinical examination and OCT
• Best corrected visual acuity in the study eye between 20 and 85 letters on the ETDRS chart (20/30 to 20/800 Snellen equivalent)
• Prior treatment with at least 6 consecutive injections with ranibizumab 0.5 mg prior to the baseline visit; the last treatment with ranibizumab should not exceed 45 days from the baseline visit.

Exclusion Criteria:

• Pregnancy (positive pregnancy test) or lactation
• Participation in another simultaneous medical investigation or trial
• Prior treatment with ranibizumab therapy in the study eye within 30 days of baseline
• Prior treatment with PDT in the study eye
• Prior intravitreal injection of a corticosteroid (triamcinolone, dexamethasone) within 120 days from baseline.
• Presence of significant subfoveal fibrosis or atrophy determined using SDOCT, fluorescein angiography and clinical examination.
• Presence of fibrous or fibrocellular material occupying more than 50% of the sub-RPE space; assessed using EDI OCT
• Presence of a RPE tear, determined by clinical examination, FA, FAF and OCT
• Intraocular surgery (including cataract surgery) in the study eye within 90 days preceding baseline
• History of pars plana vitrectomy, submacular surgery or any other surgical intervention for vitreo-retinal diseases in the study eye
• Presence of or previous history of diabetic macular edema or proliferative diabetic retinopathy.
• History of uveitis in the study eye
• Current vitreous hemorrhage in the study eye
• History of rhegmatogenous retinal detachment, macular hole and lamellar hole and in the study eye
• Ocular or periocular infection
• Active severe intraocular inflammation
• Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
• In patients with glaucoma, advanced field loss; mean deviation on threshold visual field of more than 12 decibels.
• History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
• History of allergy to fluorescein, ICG or iodine, not amenable to treatment
• Known hypersensitivity to aflibercept or to any of the excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aflibercept	Drug: Aflibercept; intravitreal aflibercept injection 2mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)	Using the Heidelberg software, subfoveal subretinal fluid (distance between the IS/OS line and the RPE line on SDOCT)	24 weeks is the primary end point of the study
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)	Measure of retinal volume (distance between the ILM and RPE outer margin on SDOCT)	24 weeks is the primary end point of the study
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)	Measure of PED height (distance between ILM and Bruchs membrane (if visible) or the horizontal line where the RPE should be present if it was not elevated)	24 weeks is the primary end point of the study
Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany)	Measure of maximal diameter of the PED (measured as the point from where the RPE detachment begins to where it ends) will be measured.	24 weeks is the primary end point of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS visual refraction at 4 meters.	Proportion of patients losing ≤ 15 ETDRS letters compared to baseline.; Proportion of patients gaining ≥ 5 ETDRS letters compared to baseline.	24 weeks is the primary end point of the study
Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS	Measure the Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT	24 weeks is the primary end point of the study

Collaborators and Investigators

• Sponsor: Vitreous -Retina- Macula Consultants of New York
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Principal Investigator: Richard Spaide, MD, Vitreous -Retina- Macula Consultants of New York

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (Estimate): December 19, 2011

Study Record Updates

• Last Update Posted (Actual): July 16, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: EVER STUDY